Ever wonder why GlaxoSmithKline CEO Andrew Witty is so interested in Africa? Well, it might be that time in Johannesburg just before Nelson Mandela was elected president. It was 1994, and the political situation was so tense there that Glaxo's staff was stockpiling food in case of civil war, the New York Times reports. Witty, then head of the office there, worked to reassure his staff--and then Mandela was elected and democracy celebrated. There and in other emerging markets where he worked--China, India, Myanmar, Pakistan, Vietnam--Witty noticed how resilient people were. They had "just…
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Andrew Witty, emerging-markets guru
9 Feb 2010 | 7:57 am -
Price hikes help lift Biogen profits
9 Feb 2010 | 7:23 amBiogen Idec said fourth-quarter earnings rose by nearly half to $306 million as price increases helped lift revenue from its multiple sclerosis drugs. Report -
Fujifilm aims for Japanese generics market
9 Feb 2010 | 7:22 amIt looks as if Big Pharma companies aiming for big sales in Japan will have some more competition. Fujifilm Holdings and Mitsubishi are planning to set up a joint venture to make--you guessed it--generic drugs, Nikkei reports. Majority-owned by Fujifilm, the venture aims to be selling 200 products as soon as this spring, the news service reported. The companies themselves wouldn't comment. This news comes on the heels of at least two major drugmakers pledging to grow Japanese sales big-time. Pfizer recently said it aims to be the No. 1 generic drugmaker in Japan. And GlaxoSmithKline chief… -
NICE to drugmakers: Share our costs
9 Feb 2010 | 7:13 amThe U.K.'s National Institute of Clinical Excellence has issued a new round of cancer-drug refusals. The drugs simply cost too much, NICE says. And to high prices, the cost-effectiveness watchdog always responds the way Queen Victoria did to a boorish guest: NICE is not amused. Indeed, this time NICE took that lack of amusement a step further with Bristol-Myers Squibb and Novartis, saying that the drugmakers should foot some of the bill for treating cancer patients with their drugs: Bristol's Sprycel ($47,500 a year), and Novartis' Tasigna (almost $50,000) and Afintor. "The cost of the drugs… -
Eli Lilly chief sees pay hike of 30%
9 Feb 2010 | 6:59 amRoll up your sleeves, folks. It's time once again to dig through the numbers on executive pay. First up: Eli Lilly chief John Lechleiter (photo). According to figures disclosed in a regulatory filing, Lechleiter scored a hefty raise in 2009. A really hefty raise, in fact: More than 30 percent. Part of the jump between 2008 and 2009 came because Lechleiter took over as CEO partway through the previous year, and in 2009 he obviously served the entire 12 months in that post. Plus, the company's 2008 performance wasn't super-special, a spokesman tells the Associated Press, meaning Lechleiter got…
- MedicalNewsToday: Pharma Industry
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Analysts: If Health Reform Fails, Expect More Industry Mergers
9 Feb 2010 | 4:00 amNews outlets report on how the fate of the health care overhaul might affect health industry mergers and biotech firms... -
Access To Private Drugs In Public Hospitals
9 Feb 2010 | 3:00 amGovernments are under increasing pressure to provide access to expensive new drugs. Canadian patients who want access to drugs that are not publicly insured are seeking to pay for these drugs within public hospitals, states an article in CMAJ (Canadian Medical Association Journal) This analysis by Colleen M... -
Cara Therapeutics Reports Positive Phase II Data For Novel Peripheral Analgesic In Acute Post-Operative Pain
9 Feb 2010 | 1:00 amCara Therapeutics, Inc. announced positive data in a Phase II proof-of-concept clinical trial of its peripherally-restricted kappa opioid agonist, CR845. The 46 patient Phase II, multi-center, double-blind, placebo-controlled study was conducted at eight hospitals in the United States and evaluated the efficacy and safety of CR845 in women following laparoscopic-assisted hysterectomy... -
Medical Breakthroughs With Biotechnology
9 Feb 2010 | 1:00 amA recent article in the Scandia Journal reported that biotechnology is helping to improve our knowledge of many devastating illnesses, and has armed patients and their doctors with exciting new diagnostics and treatments to battle disease... -
Sagent Pharmaceuticals Announces FDA Approval Of Labetalol Hydrochloride Injection, USP
9 Feb 2010 | 1:00 amSagent Pharmaceuticals, Inc., a privately held specialty pharmaceutical company, announced that it has received FDA approval of labetalol hydrochloride (HCl) injection, USP, commonly used to control severe hypertension. The product will be available in two vial sizes 100 mg per 20 mL and 200 mg per 40 mL, multi-dose vials...
- Drugs.com - Daily Med News
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ICU Patients at Risk for Rare Heart Rhythm Problem
9 Feb 2010 | 9:00 amTUESDAY, Feb. 9 -- Doctors and other health-care professionals need to be aware that certain medications can cause a rare, potentially deadly heart rhythm problem called Torsade de Pointes (TdP), says a joint scientific statement by the American... -
Tanning Bed Regulation Heats Up
9 Feb 2010 | 9:00 amTUESDAY, Feb. 9 -- Tanning beds -- America's latest health scourge -- could come under tighter regulation soon, as a result of studies linking them to cancer. The U.S. Food and Drug Administration and members of Congress are scrambling to protect... -
Drug May Ease Cognitive Effects of Huntington's
9 Feb 2010 | 9:00 amTUESDAY, Feb. 9 -- An experimental drug may improve thinking, learning and memory skills in people with Huntington's disease, an inherited neurodegenerative disorder, new research says. Huntington's affects movement, behavior and cognitive... -
Clinical Trials Update: Feb. 9, 2010
9 Feb 2010 | 7:30 am-- Here are the latest clinical trials, courtesy of ClinicalConnection.com: Smoking Cessation This year-long study will evaluate an investigational vaccine to aid in smoking cessation. To qualify, you must be aged 18 to 65, and have smoked more then... -
Health Highlights: Feb. 9, 2010
9 Feb 2010 | 6:47 amHere are some of the latest health and medical news developments, compiled by the editors of HealthDay: New Guidelines Coming on Use of Newborn Blood Samples U.S. government advisers say new national recommendations that will give parents more...
- Drugs.com - Pharma Industry News
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Amgen Sees Positive Data In Bone Drug Study
9 Feb 2010 | 8:07 amFrom Associated Press (February 9, 2010) THOUSAND OAKS, Calif. -- Amgen Inc. said its osteoporosis drug candidate denosumab beat a rival drug in reducing and delaying the rate of fractures in men with prostate cancer during a study. The drug, also... -
Glaxo Considering Job Cuts At UK Research Center
9 Feb 2010 | 7:53 amFrom Associated Press (February 9, 2010) LONDON -- Drug maker GlaxoSmithKline PLC said Tuesday that it has begun consultations with workers on cutting jobs at a British research facility, an early step in its plans announced a week ago to shift its... -
Pfizer Teams Up to Offer Online Health Management
9 Feb 2010 | 7:05 amPfizer Teams Up to Offer Online Health Management [The Day, New London, Conn.] From Day, The (New London, CT) (February 9, 2010) Feb. 9--Drug giant Pfizer Inc. is teaming up with San Francisco-based interactive-technology firm Keas Inc. to... -
Biogen 4Q Profit Grows 48 Percent On Tysabri Sales
9 Feb 2010 | 6:40 amFrom Associated Press (February 9, 2010) CAMBRIDGE, Mass. -- Biogen Idec Inc. said Tuesday its profit rose 48 percent in the fourth quarter due to higher sales of its drug Tysabri, a treatment for multiple sclerosis and Crohn's disease. The... -
Biogen Idec Reports Full Year and Fourth Quarter 2009 Results
9 Feb 2010 | 6:40 am13% Non-GAAP and 26% GAAP Diluted EPS Growth Over Prior Year; TYSABRI In-Market Sales Exceeded $1 Billion CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 9, 2010 - Biogen Idec Inc. (NASDAQ: BIIB), a global biotechnology leader in the discovery, development,...
- WorldPharma News
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Pfizer and Keas Partner to Help Consumers Take a More Active Role in Their Health and Wellness
8 Feb 2010 | 3:01 pmPfizer and Keas announced today they have entered into an alliance to collaborate on the Keas platform to enable Health and Wellness experts to author, sell and distribute personalized online Care Plans directly to patients. -
analytica InnovationArea: Start-ups in the Spotlight
8 Feb 2010 | 3:00 pm23-26 March 2010, Munich, Germany. Following its successful premiere in 2008, analytica, the leading trade fair for industrial analysis, laboratory technology and biotechnology, will continue its initiative for new companies again in 2010. -
GSK launches new specialist unit to research and develop medicines for rare diseases
7 Feb 2010 | 3:00 pmGlaxoSmithKline (GSK) has announced the formation of a new standalone unit specialising in the development and commercialisation of medicines for rare diseases. Over 5,500 rare diseases have been identified(1) of which less than 10% are currently being treated(2), presenting a significant unmet medical need. -
Strong operating performance for Roche in 2009
4 Feb 2010 | 3:01 pmThe total Roche Group's sales grew by 10% in local currencies (8% in Swiss francs; 7% in US dollars) to 49.1 billion Swiss francs, with the Pharmaceuticals Division accounting for 80% of Group sales and the Diagnostics Division contributing 20%. Sales growth in both divisions exceeded market growth. -
First Health 2.0 Europe Conference to be Held in Paris
4 Feb 2010 | 3:00 pmHealth 2.0 Europe, a conference dedicated to how Web 2.0 and social media are transforming healthcare systems in Europe, will be held, for the first time, on April 6-7, 2010 at the Cité Universitaire International in Paris, France.
- BNET Pharma
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Biogen (BIIB) Reports Q4 Adj-EPS of $1.20, Beats by 15c; Guides FY10 Above the Street
9 Feb 2010 | 9:39 amBiogen Idec Inc. (NASDAQ: BIIB) reports Q4 EPS of $1.20, ex-items, 15 cents better than the analyst estimate of $1.05. Revenue for the quarter was $1.1 billion, which compares to the estimate of $1.13 billion. Sees FY10 adj-EPS above $4.55. The Street is currently looking for FY10 EPS of... NewsBlaze - Biogen Idec Reports Full Year and Fourth Quarter 2009 Results RTTNews.com - Biogen Idec To Report Q4 Results: Earnings Preview -
Medivation's Dimebon turns in promising results for Huntington's
9 Feb 2010 | 8:59 amThe drug Dimebon, which has shown some significant promise for Alzheimer's, has now registered positive results in a trial designed to test the therapy's ability to improve thinking, learning and memory skills for people who suffer from Huntington's. Dr. Karl Kieburtz of the University of... FierceBioResearcher - Medivation's Dimebon turns in promising results for Huntington's -
Amgen: Denosumab demonstrates superiority over Zometa
9 Feb 2010 | 8:17 amAmgen's denosumab was more effective than Roche's Zometa (zoledronic acid) in delaying fractures in men with advanced prostate cancer, according to results of 1,901-patient Phase III trial. In fact, denosumab outperformed Zometa by 18 percent in delaying the time before patients suffered a... Scrip News - Amgen's Prolia beats Zometa in final Phase III bone metastases trial -
Lechleiter pay rises 54% in 1st full year as Lilly CEO - Yahoo! Finance
9 Feb 2010 | 7:42 amBy Tom Murphy, AP Business Writer , On Monday February 8, 2010, 4:50 pm EST INDIANAPOLIS (AP) -- Eli Lilly and Co. CEO John Lechleiter received a compensation package valued at $16.4 million for 2009, up 54 percent from 2008, the year he became the drug maker's chief executive, according to an... FiercePharma - Eli Lilly chief sees pay hike of 30% -
Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and Commercialisation
9 Feb 2010 | 7:06 amA Potent, First-in-class Antiviral Agent for the Treatment of Hepatitis CLAUSANNE, Switzerland, February 9 /PRNewswire/ -- Debiopharm Group (Debiopharm), a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical... Forbes.com - Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and... SYS-CON Media - Debiopharm Group Grants an Exclusive Licence for the Development, Manufacture and Commercialisation of Debio 025
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Sanofi-Aventis Signs Agreements to Establish New Consumer Healthcare Joint Venture in China with Minsheng Pharmaceutical Group
9 Feb 2010 | 12:00 am -
Enhancing Collaboration with the FDA Through MedWatch Plus
8 Feb 2010 | 12:00 amThis white paper will provide an overview of the benefits and best practices of using the FDA's MedWatch Plus initiative for electronic adverse event reporting within the pharmaceutical industry, as well as other FDA-regulated organizations. -
EMA Releases Road Map Through 2015
8 Feb 2010 | 12:00 am -
One-Third of Antimalarial Medicines Sampled in Three African Nations Found to be Substandard in Large-Scale USP-WHO Study
8 Feb 2010 | 12:00 am -
Biotech Responds to Dramatic Changes to Innovate in 2010 and Beyond
5 Feb 2010 | 12:00 amA series of articles include 'Partners in Survival: Biotech executives respond to the dramatic changes in the world,' 'The Year that Wasn’t: Even when raising money is hard, having a revenue-generating business can ensure longevity,' and '10 Fellow Travelers: Big Pharma’s move toward targeted therapeutics is fueling dealmaking between drug and diagnostics companies.'
- MedWorm: Pharmaceuticals
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CEO Brondeau buys $1M in FMC stock
9 Feb 2010 | 5:54 amThe president and CEO of FMC Corp. bought $1 million of the chemical company’s stock. (FMC) (Source: bizjournals.com Health Care:Pharmaceuticals headlines)MedWorm Message: Get the very latest Swine Flu news via the MedWorm Swine Flu RSS news feed - updated hourly from thousands of authoritative health and news sources. -
Rand dipped in 4Q
9 Feb 2010 | 5:51 amBuffalo business development company Rand Capital Corp. issued a fourth quarter financial report which showed the net asset value of its shares fell 2 cents to $3.40. (RAND) (Source: bizjournals.com Health Care:Pharmaceuticals headlines) -
Bark Group Inc.: Bark Group Inc. Signs LOI to Acquire 10% Stake in Research Company Mindmetic
9 Feb 2010 | 5:51 amNEW YORK, NY (MARKET WIRE) Bark Group Inc. (OTCBB: BKPG), a U.S. company with a multinational client base, announced today that the Company has signed a Letter of Intent to acquire a 10% stake in Mindmetic, a brain research company that develops neuromarketing research methods. (Source: Market Wire - Pharmaceuticals and Biotech) -
Miraculins Inc.: Miraculins Announces Private Placement Offering
9 Feb 2010 | 5:50 amWINNIPEG, MANITOBA (MARKET WIRE) Miraculins Inc. (TSX VENTURE: MOM), a medical diagnostic company focused on developing and commercializing diagnostic tests for unmet clinical needs, today announces a non-brokered private placement offering (the "Offering") of up to 7,150,000 units ("Units") at a price of $0.07 per Unit for gross proceeds of up to $500,500. Each Unit will be comprised of one common share of the Company (a "Share") and one Share purchase warrant (a "Warrant"). Each Warrant will entitle the holder to purchase one Share at a price of $0.10 per Share for a period of 12 months… -
S3 Investment Company: S3 Investment Company Comments on Additional Contracts Valued at Over $57 Million Announced by Redwood Capital Client
9 Feb 2010 | 5:44 amDANVILLE, CA (MARKET WIRE) S3 Investment Company, Inc. (PINKSHEETS: SIVC) today commented on three new construction contracts valued at over $57 million announced by a client of its Redwood Capital subsidiary. The new contracts were announced by Boyuan Construction Group, which is publicly traded on Canada's TSX Venture Exchange under the symbol BOY, and include two projects in Shandong province and one on Hainan Island, China. Redwood Capital, as part of the compensation it received as the Chinese merchant banking advisor for Boyuan Construction Group when it became listed on Canada's TSX…
- Topix: Pharma News
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More On Pharma's Ugly Finances
9 Feb 2010 | 8:18 amDerek Lowe, an Arkansan by birth, got his BA from Hendrix College and his PhD in organic chemistry from Duke before spending time in Germany on a Humboldt Fellowship on his post-doc. He's worked for several major pharmaceutical companies since 1989 on drug discovery projects against schizophrenia, Alzheimer's, diabetes, osteoporosis and other ... -
Continuity at the Head of the Management Board
9 Feb 2010 | 6:52 amThe Supervisory Board has received this decision with regret and in its meeting today appointed as Herberg's successor from June the Management Board member of many years' standing, Uwe Rohrhoff . -
Denosumab Demonstrated Superiority Over Zometa(R) In Pivotal Phase 3...
9 Feb 2010 | 1:51 amMain Category: Prostate / Prostate Cancer Also Included In: Bones / Orthopaedics Pharma Industry / Biotech Industry Amgen announced that a pivotal, Phase 3, head-to-head trial evaluating denosumab versus Zometa in the treatment of bone metastases in 1,901 men with advanced prostate cancer met its primary and secondary endpoints. -
Cara Therapeutics Reports Positive Phase II Data For Novel Peripheral ...
9 Feb 2010 | 1:51 amMain Category: Pain / Anesthetics Also Included In: Pharma Industry / Biotech Industry Cara Therapeutics, Inc. -
APCER Pharma Announces That LPC Pharma Group To Outsource Pharmacovigilance/Drug Safety To APCER
9 Feb 2010 | 1:47 amMain Category: Pharmacy / Pharmacist Also Included In: Pharma Industry / Biotech Industry Article Date: 09 Feb 2010 APCER Pharma announced that LPC Pharma Group is outsourcing its http://www.pharmacovigilance/drug safety operations to APCER.
- InPharmaTechnologist
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MDRNA’s formulation stable after 12 months
9 Feb 2010 | 2:00 amMDRNA’s liposomal drug delivery formulation, DiLA2, lost no potency when stored for 12 months in conditions ranging from -80ºC to 4ºC, helping to validate it for administration of UsiRNA. -
FDA: drug safety benefits of import inspection system easy to Predict
9 Feb 2010 | 2:00 amThe US FDA says its new screening system will expedite the importation of genuine drugs and help inspectors focus their efforts on “high risk” products. -
Berlin Packaging to buy All-Pak
9 Feb 2010 | 2:00 amBerlin Packaging has agreed to acquire All-Pak, creating a combined company with annual revenues of $500m (€365m) and an expanded geographic, including Puerto Rico. -
Almost half of antimalarials in Senegal are substandard; study
9 Feb 2010 | 2:00 amAlmost half of antimalarials in Senegal are substandard, according to a USP study which will be used by local regulators to focus efforts on high-risk products, brands and geographies. -
Actavis to boost tablet capacity; and looking at Ratiopharm
8 Feb 2010 | 2:00 amIcelandic generics firm Actavis says expansion of its tablet plant will boost production capacity 50 per cent and create 50 new jobs.
- Pharma Marketing Blog
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FDA Blasts Lilly's PAH eCommunity Videos!
8 Feb 2010 | 9:18 amIn a Notice of Violation letter to Lilly (see here), FDA cited two videos supposedly submitted by patients who take ADCIRCA, Lilly's drug approved for the treatment of Pulmonary Arterial Hypertension (PAH).The patient videos present statements made by Adcirca users, “Traci” and “Carolyn" who make the following claims among others:“I can walk, and stairs don’t bother me [after Adcirca treatment] . . . . Bending over used to make me breathless, picking up my cat used to make me breathless and it doesn’t affect me anymore.”“Exercising and stairs and heat used to bother me and it… -
Hallelujah! The Recession is Over! Sales of "Lifestyle" Drugs Like Botox & Cialis On the Rebound.
8 Feb 2010 | 7:15 amAs reported over at minyanville.com ("Sign of the Times? Cosmetic Surgery Is Back"):According to a survey done by MEDACorp, plastic surgery and cosmetic procedures were up during the fourth quarter [of 2009] for the first time since the downturn began in 2007.The survey encompassed facial injectibles, breast implants, laser procedures, and Latisse for eyelash growth. The results of the survey indicated that procedures for botulinum toxins like Allergan’s (AGN) Botox and facial fillers like Medicis Pharmaceutical’s (MRX) Restylane increased the most year-over-year in the fourth quarter of… -
Danica Patrick: NASCAR Driver, Super Model, Superbowl Lingerie Ad Model, & COPD Spokesperson All Rolled Into one!
5 Feb 2010 | 1:00 amLately, I and about 1000 other people who "follow" @boehringerus (Boehringer Ingelheim) on Twitter have been getting several messages like this one:#4COPD robs people of their ability to breathe. Get screened 2 see if UR at risk & talk to your Dr about your results http://ow.ly/13VknIt's part of a huge effort to roll out the new "DRIVE4COPD" campaign that BI is sponsoring. BI is jamming its Twitter account with similar messages (see image on left, click to enlarge).This is a huge social media campaign that involves not only Twitter but also Facebook, Flickr, and YouTube. It features the… -
Did Cephalon Pay James Mcmillen $101,650 to Help Promote Actiq for Off-Label Use?
4 Feb 2010 | 2:08 pmIn a recent post, I wondered why a doctor from Dillsberg, PA, a town with a total area of 0.8 square miles and only 2,063 people, would be the 5th highest paid physician on Cephalon's list of payments to physicians. That doctor -- James Mcmillen -- received $101,650 in 2009 (see "Transparency Vs. Translucency in Reporting Physician Payments").Since I first posted this bit of information, I learned that:(1) Cephalon agreed to plead guilty to promoting painkiller Actiq, narcolepsy pill Provigil and the epilepsy treatment Gabitril for uses that weren’t approved by FDA. As a result of the plea… -
FDA Warns Meda Pharmaceuticals that Astelin Isn't Approved as a Cure for House Cleaning!
4 Feb 2010 | 11:48 amDEPARTMENT OF HEALTH & HUMAN SERVICES Public Health ServiceFood and Drug Administration Silver Spring, MD 20993TRANSMITTED BY FACSIMILERichard Fosko, RPh, MPH, Director Regulatory Affairs Meda Pharmaceuticals, Inc. 265 Davidson Avenue, Suite 300 Somerset, NJ 08873-4120RE: NDA #20-114ASTELIN®(azelastine hydrochloride) Nasal SprayMACMIS #18201Dear Mr. Fosko:As part of its routine monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a waiting room sign (sign), entitled “Astelin ‘House Cleaning’ Waiting Room Sign”…
- BioSpace.com
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Adeona Pharmaceuticals Appoints M.D., M.B.A., as Chairman, CEO and President
9 Feb 2010 | 4:00 amvar addthis_pub"bdwyer"; -
University of California, Los Angeles (UCLA) Researchers Reveal 3-D Structure Of Bullet-Shaped Virus With Potential To Fight Cancer, HIV
9 Feb 2010 | 4:00 am(PhysOrg.com) -- Using cryo-electron microscopy and advanced image-processing methods, UCLA researchers have developed a model of how the potentially therapeutic vesicular stomatitis virus assembles. -
Are Big Pharmaceutical Companies Exploiting The Recession?
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Drug Shows Promise Against River Blindness, The Scripps Research Institute Study
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Debiopharm Grants Novartis Corporation Exclusive Licence for the Development, Manufacture and Commercialisation of Debio 025
9 Feb 2010 | 4:00 amvar addthis_pub"bdwyer";
- Drugs.com - New Drug Approvals
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Labopharm Receives FDA Approval for Oleptro
3 Feb 2010 | 7:54 amLAVAL, QC and PRINCETON, NJ, Feb. 3 /PRNewswire-FirstCall/ -- Labopharm Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Oleptro (trazodone hydrochloride) Extended Release Tablets, a novel once-daily formulation of... -
Auxilium Announces U.S. Food and Drug Administration Approval for Xiaflex for the Treatment of Dupuytren's Contracture
3 Feb 2010 | 7:53 amMALVERN, Pa., Feb. 3 /PRNewswire/ -- Auxilium Pharmaceuticals, Inc., a specialty biopharmaceutical company, just announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for Xiaflex (collagenase... -
GSK's Tykerb Receives Accelerated Approval for First-Line Combination Treatment of Metastatic Breast Cancer
1 Feb 2010 | 6:04 amPHILADELPHIA, Jan. 29 /PRNewswire/ -- GlaxoSmithKline announced today that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for a new combination regimen using Tykerb (lapatinib) as a first-line, all-oral treatment for... -
FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
29 Jan 2010 | 5:43 amApproval is part of Agency's unapproved drugs initiative SILVER SPRING, Md., Jan. 26 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Morphine Sulfate Oral Solution for the relief of moderate to severe, acute and... -
U.S. Food and Drug Administration Approves Labeling Update for Prezista To Include 96-Week Data in HIV-1 Infected Adult Patients
28 Jan 2010 | 5:50 amBRIDGEWATER, N.J., Jan. 27 /PRNewswire/ -- Tibotec Therapeutics announced today that the U.S. Food and Drug Administration (FDA) has approved a labeling update for Prezista (darunavir) tablets to include 96-week data from the ARTEMIS and TITAN...
- Drugs.com - New Drug Applications
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XenoPort Announces Horizant as Brand Name for XP13512
4 Feb 2010 | 11:31 amSANTA CLARA, Calif.--(BUSINESS WIRE)--Feb 4, 2010 - XenoPort, Inc. announced today that, subject to the approval of the U.S. Food and Drug Administration (FDA), the brand name for GSK1838262/XP13512 (gabapentin enacarbil) in the United States... -
Lux Biosciences Files for Luveniq Approval in US and Europe for Noninfectious Uveitis
4 Feb 2010 | 11:12 amJERSEY CITY, N.J.--(BUSINESS WIRE)--Feb 4, 2010 - Lux Biosciences, Inc. today announced its submission of simultaneous regulatory filings to both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking... -
FDA Accepts Javelin Pharmaceuticals' Dyloject New Drug Application for Formal Review
2 Feb 2010 | 11:51 amNDA for Management of Acute Moderate-to-Severe Pain Includes Data from 16 Clinical Studies CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb 2, 2010 - Javelin Pharmaceuticals, Inc., a leading developer and marketer of specialty pharmaceutical products for... -
Teva Announces FDA Accepts BLA for XM02
2 Feb 2010 | 11:16 amJERUSALEM--(BUSINESS WIRE)--Feb 2, 2010 - Teva Pharmaceutical Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing Teva's Biologics License Application (BLA) for XM02, a... -
Protalix Announces NDA Submission Update for taliglucerase alfa for the Treatment of Gaucher Disease
2 Feb 2010 | 4:24 amCARMIEL, Israel, Feb. 2 /PRNewswire-FirstCall/ -- Protalix BioTherapeutics, Inc. (NYSE Amex: PLX) announced today that, in connection with the New Drug Application (NDA) filed by the Company in December 2009 for taliglucerase alfa for the...
- Drugs.com - Clinical Trials
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Cerus Corporation Reports Positive Outcome of Phase 1 Clinical Trial of INTERCEPT Red Blood Cells
9 Feb 2010 | 9:02 amData Supports Advancement of Product Development CONCORD, Calif.--(BUSINESS WIRE)--Feb 9, 2010 - Cerus Corporation (NASDAQ:CERS) announced today that its Phase 1 trial of red blood cells treated with the INTERCEPT Blood System met its primary... -
Denosumab Demonstrated Superiority Over Zometa in Pivotal Phase 3 Head-to-Head Trial in Prostate Cancer Patients With Bone Metastases
9 Feb 2010 | 5:53 amDenosumab Trial Met Primary and All Secondary Endpoints by Significantly Delaying Time to First Skeletal Related Event and Significantly Reducing First-and-Subsequent Skeletal Related Events Compared to Zometa Second Phase 3 Advanced Cancer Trial... -
ThromboGenics - Positive Microplasmin Phase II Data Published in Ophthalmology
9 Feb 2010 | 5:47 am- Paper Examines the Potential of Microplasmin to Improve the Treatment of a Range of Back of the Eye Diseases LEUVEN, Belgium, February 9/PRNewswire-FirstCall/ -- ThromboGenics NV (Euronext Brussels: THR), a biopharmaceutical company focused on the... -
AMAG Pharmaceuticals Provides Feraheme® Safety Update
8 Feb 2010 | 11:45 am~ Conference call will be held today at 4:45 p.m. Eastern time ~ LEXINGTON, Mass.--(BUSINESS WIRE)--Feb 5, 2010 - AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG), a biopharmaceutical company focused on the development and commercialization of a... -
Researchers Report Elevated Levels of Tβ4 Levels Predict Patient Survival in Hepatitis B Virus-related Liver Failure
8 Feb 2010 | 11:41 amTβ4 – Potential New Therapeutic Agent for Liver Failure BETHESDA, Md.--(BUSINESS WIRE)--Feb 8, 2010 - REGENERX BIOPHARMACEUTICALS, INC. (NYSE Amex:RGN) announced today that researchers have correlated Tβ4 levels with...
- Pharmainfo.net
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Reportlinker Adds Chronic Obstructive Pulmonary Disease (COPD) - Drug Pipeline Analysis and Market Forecasts to 2016
9 Feb 2010 | 11:05 amReportlinker Adds Chronic Obstructive Pulmonary Disease (COPD) - Drug Pipeline Analysis and Market Forecasts to 2016 read more -
UK Says Novartis AG, Bristol-Myers Squibb Co. Cancer Drugs Too Costly-Reuters
9 Feb 2010 | 11:05 amUK Says Novartis AG, Bristol-Myers Squibb Co. Cancer Drugs Too Costly-Reuters Reuters Key Development - 19 hours ago -
Reportlinker Adds Acute Coronary Syndrome - Drug Pipeline Analysis and Market Forecasts to 2016
9 Feb 2010 | 10:56 amNEW YORK, Feb. 9 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Acute Coronary Syndrome - Drug Pipeline Analysis and Market Forecasts to 2016 http://www.reportlinker.com/p0176371/Acute-Coronary-Syndrome---Drug-Pipe... -
Ligon Discovery and Lycera Collaborate to Develop First-in-Class Drugs for Immune Disorders
9 Feb 2010 | 10:52 amCAMBRIDGE, Mass., Feb. 9 /PRNewswire/ -- Ligon Discovery announced today that it has entered into a collaboration agreement with Lycera Corporation to apply its Small Molecule Microarray (SMM) screening technology to identify first-in-class drug candidates for immune disorders. Ligon will apply its -
Reportlinker Adds Atrial Fibrillation - Drug Pipeline Analysis and Market Forecasts to 2016
9 Feb 2010 | 10:48 amNEW YORK, Feb. 9 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue: Atrial Fibrillation - Drug Pipeline Analysis and Market Forecasts to 2016 http://www.reportlinker.com/p0176366/Atrial-Fibrillation---Drug-Pipeline...
- JNJ BTW
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More Perspectives on Text4Baby
8 Feb 2010 | 10:09 amI just had a chance to go through some of the online chatter about the announcement last week of the new Text4Baby mobile phone service that provides useful information for new and expectant moms. There are some more details on what this service means on the JNJ.com website (Johnson & Johnson is one of the founding sponsors) as well as on JNJBTW and BabyCenter, but I thought I would highlight a few of the posts I came across: 1) MobiHealthNews provides a snapshot of how mobile services are being used around the world to improve health literacy, highlighting a presentation made by Paul… -
White House Launches text4baby
4 Feb 2010 | 12:01 pmWhen my son Alex was small, his baby sitter told us of a horrible personal tragedy that befell her young niece. This seemingly healthy young woman died in childbirth. As the details of the tragedy came to light it became apparent to me – and the family — that with proper prenatal care, the outcome may have been different. Earlier today, the White House announced the launch of a new public health initiative, text4baby – the US’s first-ever free mobile health service that provides timely and expert health information through SMS text messages for pregnant women and new moms. -
Chairman and CEO Bill Weldon Highlights Johnson & Johnson’s Strategic Framework
26 Jan 2010 | 10:24 amI thought I would also highlight one other topic covered during the earnings call today. In addition to focusing on a common value system as defined by the company’s Credo, for many years, Johnson & Johnson has worked under an operating model that includes being broadly based in human health care, managing the business for the long term, taking a decentralized management approach and focusing on employees and the company’s value system. Within this strategic framework, the company will rally around common, high level priorities that reflect the current environment and the… -
Reflecting on the Past Two Years
26 Jan 2010 | 10:23 amAt the beginning of each year, most people reflect on what they had accomplished over the previous twelve months and consider whether they met their own personal goals and expectations. Though most of us do this routinely – usually during the aftermath of New Year’s Eve – we often forget that organizations need to do the same. In his remarks to analysts today to discuss the fourth quarter 2009 earnings, Chairman and CEO Bill Weldon took a look back at what was said back in 2008 and then to see what the company has accomplished. So what exactly were those accomplishments? You can listen… -
Chairman and CEO Bill Weldon Provides Additional Context on the McNeil Recall
26 Jan 2010 | 10:20 amDuring the earnings call earlier today, Chairman and Chief Executive Officer Bill Weldon provided some further context around the recent recall announcement by McNeil Consumer Healthcare. In his remarks to financial analysts Bill provided a more detailed account of what the investigation entailed and the complexities of identifying the source of the odor, which I have reprinted here for those who are interested: “We’re very conscious of the bar we set for ourselves and that consumers expect more from us than from others because of our history and reputation. Our recent consumer…
- Merck.com - Product News
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U.S. District Court Rules Against Merck in TEMODAR (temozolomide) Patent Lawsuit
25 Jan 2010 | 4:00 pm -
FDA Approves ZEGERID OTC™ for Over-the-Counter Treatment of Frequent Heartburn
30 Nov 2009 | 4:00 pm -
U.S. Department of Health & Human Services Recommends Merck's First-in-Class Integrase Inhibitor ISENTRESS (raltegravir) Tablets, in Combination Therapy, as a Preferred Regimen for Treatment-Naïve Patients with HIV-1 Infection
30 Nov 2009 | 4:00 pm
- Pharm Blog Review
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Happy new year, sort of
15 Jan 2010 | 3:15 pmYes, the Pharma Blog Week in Review is back. I had to take a break from it over the holidays; I even became so silent on Twitter that I had a few folks ask me if I was all right. But I knew I’d get back into the swing of things in the new year. And what a week to get back into it. It kicked off the with the J.P. Morgan Healthcare Conference in San Francisco, was punctuated by the devastating earthquake in Haiti, accented by the FTC urging Congress for legislation against pay-for-delay deals between pharma and generics companies, the Government Accountability Office finding extraordinary… -
J&J job cuts kick off week
6 Nov 2009 | 1:35 pmIt’s a mixed bag this week in pharma industry news (much like that sack of your kids hauled home from their trick-or-treating, for every KitKat, there’s a bag of candy corn). Some of the notable items: Johnson & Johnson announced the company would be reducing its headcount by 7% (and Eli Lilly also announced some layoffs in Indiana); now that Merck & Co. is the No. 2 drugmaker, the company is poised for future buys (but FDA would not accept Merck’s application for a combination cholesterol pill); GlaxoSmithKline and Pfizer launched their joint HIV venture, ViiV… -
For Halloween, some bloggy treats (no tricks)
30 Oct 2009 | 1:04 pmHalloween is tomorrow, but for the pharmaceutical industry, the real “party” will be November’s two-day meeting on social media use, sponsored by FDA. Everyone is hoping the hearing will yield a treat (in the form of a workable guidance on social media) and not tricks (in the form of FDA remaining inscrutable and issuing warning letters). This week was yet another conference, ePatient Connections in Philadelphia sponsored by Kru Research; although the main focus was communicating with empowered patients, there was another discussion about the pharma industry’s use of… -
Pharma still uneasy about getting social
23 Oct 2009 | 12:51 pmThis week was full and frantically busy, and I am not just talking about the three days I drove back and forth to Bridgewater, N.J., for ExL Pharma’s Digital Pharma conference (if you want the quick lowdown on what happened there, you can find the Tweets, from me and many others, under the hashtag #DigPharm). This week, AstraZeneca offered a buyout to all of its sales representatives (and Pharmalot broke the news); Pfizer started handing out layoffs to most of the former Wyeth sales force; FDA sent a warning letter to King Pharmaceuticals over two video news releases about the pain drug… -
Pfizer pfuels burst of blogger speculation
16 Oct 2009 | 1:31 pmThe week ended in a big way, as Pfizer’s acquisition of Wyeth became final and FDA approved GlaxoSmithKline’s Cervarix vaccine for cervical cancer. Also, debate continued about the healthcare reform bill passed by the Senate Finance Committee last week. And fortunately for the industry, no recent bombs about ghostwriting or other scandals hit the air. (The cynical side of me says just give it some time, though.) One big happy family Jacob Goldstein at the Wall Street Journal Health Blog gathered some news about which Pfizer and Wyeth sites would be staying open and which would be…
- Pharma Strategy Blog
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#ePharma Annual Summit: leveraging innovative digital marketing strategies
8 Feb 2010 | 8:17 amThe ePharma summit is taking place this week in Philadelphia. Today is the social media boot camp for newbies interested in getting started with social media and tomorrow the main meeting starts with some interesting speakers lined up, including sanofi-aventis's Dennis Urbaniak and Mike Fowler from Eli Lilly. You can follow the tweets using the #epharma hashtag on Twitter or for ease of use you can click the widget below to see the aggregated tweets in one stream. You can also catch it live or even later, if you want to get a summary and scan after the event or at the end of the day. <a… -
FDA and ODAC to review $CTIC's pixantrone and $CXSPY's omacetaxine
8 Feb 2010 | 6:57 amThis week, (10th February) the FDA's Oncologic Drugs Advisory Committee will be meeting to review the filings from Cell Therapeutics ($CTIC) and ChemGenix ($CXSPY) for pixantrone and omacetaxine, in relapsed refractory NHL and CML, respectively. I've just taken a few minutes to read the briefing documents and here are my initial thoughts. Cell Therapeutics, a Seattle based biotech company, are going to have a very tough morning on Wednesday in DC for the following reasons: The pivotal study had a very poor accrual with only 140 out of 320 patients enrolled. Substantial cardiac and… -
The Biotech IPO isn't dead yet!
8 Feb 2010 | 5:36 amRecently, I noticed that oncology companies are in the news for raising new financing or even announcing IPO's, and wondered if that was an anomaly after the credit shutdown following the Wall St crisis. In general, my perception was that they seemed to be down overall. To find out more, I checked out the VC funding statistics at OnBioVC: Surprisingly, oncology dominates the market at the moment, with the latest data being available from 3Q09: nearly one-third were from oncology alone during that period. According to the report, they represented:"... a diverse therapeutic approach; from… -
Why did Roche's Avastin lose steam in 4th quarter 2009?
5 Feb 2010 | 8:42 amThis snippet from Reuters posted earlier this week while I was listening to the Roche earnings call in Basle, which was a nicely put together presentation:"Roche Holding AG overhauled the sales efforts for its best-selling drug, the Avastin cancer treatment, after the company “lost steam” during the fourth quarter. Sales of the medicine were hurt by a focus on selling it as a treatment for breast tumors, Pascal Soriot, the head of the pharmaceuticals division, said in an interview today. The company beefed up marketing by assigning the sales team responsible for the Herceptin breast… -
Why I read PharmaGossip on Fridays
5 Feb 2010 | 8:03 amBecause he makes me laugh out loud with posts like this: No, I'm not going to spoil the fun - go and check out his story here.
- Pharma's Cutting Edge
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The end of PCE?
In case you are one of the folks who subscribe to my RSS feed or just found the site and were wondering why there have been no posts since April, this note's for you. Here's the truth. I enjoy writing the occasional editorial on our industry, and I especially enjoy it ... -
Provenge success definitive now it seems
I last wrote about Dendreon's Provenge active immunotherapy for prostate cancer back in May of 2007, when I raised questions about FDA's decision not to approve the therapy, despite a favorable advisory committee opinion. Today, I am happy to pass along news of positive top-line results from a confirmatory Phase 3 ... -
A case study of publication bias
Have a look at a recent paper by an osteopath with strong anti-industry sentiment who nevertheless manages to put together a study that systematically (and mostly fairly) examines the biases evident among published reviews of rimonabant. I say "mostly fairly", because I found the editorializing to be all over the place, an anti-industry ...
- PharmaGossip
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The East Herts Herald - MP Writes To GlaxoSmithKline Over Looming Job Cuts
9 Feb 2010 | 10:33 amvia herald24.co.uk Posted via web from Jack's posterous -
Beer boosts bones and fends off osteoporosis - Telegraph
9 Feb 2010 | 10:33 amvia telegraph.co.uk Mine's a pint. Cheers! Posted via web from Jack's posterous -
NICE Says Novartis, BMS Cancer Drugs Too Expensive
9 Feb 2010 | 10:11 amThe independent National Institute for Clinical Excellence provisionally rejected Switzerland-based Novartis' Tasigna and U.S.-based Bristol-Myers Squibb' Sprycel for chronic myeloid leukaemia in patients who are intolerant to imatinib (an older Novartis drug whose brand name is Gleevec) saying evidence to support their effectiveness was "very poor" and their cost was "extremely high". The independent agency also rejected Novartis's tumor treatment Afinitor as a second-line treatment for advanced kidney cancer in a draft ruling. via advfn.com Posted via web from Jack's posterous -
The HCC interviewed Dr. Gordon Guyatt to discuss the major flaws in the way the Crestor JUPITER trial was conducted and reported.
9 Feb 2010 | 7:44 amSource -
Lechleiter pay rises 54% in 1st full year as Lilly CEO - Yahoo! Finance
9 Feb 2010 | 7:42 amBy Tom Murphy, AP Business Writer , On Monday February 8, 2010, 4:50 pm EST INDIANAPOLIS (AP) -- Eli Lilly and Co. CEO John Lechleiter received a compensation package valued at $16.4 million for 2009, up 54 percent from 2008, the year he became the drug maker's chief executive, according to an Associated Press calculation of figures disclosed Monday in a regulatory filing. Also president and chairman, his salary rose nearly 11 percent to $1.48 million and his performance-related cash bonus jumped 31 percent to $3.55 million.Lechleiter, 56, also was granted stock valued at $11.25 million when…
- Pharma 2.0
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Pharma review sites
9 Feb 2010 | 9:40 amIn the past I have written about drug review sites like iGuard.org. Social/digital pharma blogger extraordinaire Jon Richman recently wrote a post about “The Best Pharma Products According to Patients” on Dose of Digital. He provides deep analysis about iGuard in particular which has over 2 million users at this point. Briefly though the 4 sites he has been tracking are: iGuard eHealthMe eDrugSearch PrescriptionDrug-Info It’s good to know about these sites if you’re in the industry and what to know what people are saying about your product(s). Take a look. -
Check out ScienceRoll
4 Feb 2010 | 7:48 amI do not know Bertalan Mesko, MD personally but this Hungarian physician and PhD-to-be in personalized genomics publishes some of the best content related to Health 2.0 on the Web. His blog is ScienceRoll and he tweets @berci. Bertalan has assembled an incredible list of online/2.0 resources by specialty on his consulting site Webcina. Colleagues frequently come into my office and ask, “I need to get up to speed on [insert disease], where should I look online?” Now I have a great place to send them in many cases. The evolving list includes: Dermatology and Web 2.0 Cardiology and… -
#SocPharm and AZ Helps
8 Jan 2010 | 9:47 amMy friend and fellow social media evangelist Eileen O’Brien has launched a weekly Tweetchat about social media and pharma. I stumbled upon it on Wednesday night (1/6) and joined in near the end when Eileen mentioned AZ Helps – a sort of help desk offering from AstraZeneca that uses Twitter. I didn’t even know about it so quickly looked at their Twitter page. AZ is monitoring Twitter and doing proactive outreach to posters who mention problems with access to Nexium or even adverse events. The posts are primarily this: @[twitteruser]: Saw your tweet about access to NEXIUM®… -
Pharma and Healthcare Social Media Wiki
8 Dec 2009 | 11:59 amI have no clue when Jonathan Richman has time to sleep or work given all of the information he gathers and publishes on his blog Dose of Digital. One of the best areas on his site is the Pharma and Healthcare Social Media Wiki. It is chock full of real-world examples of digital/social marketing in pharma and other parts of healthcare. Below is how the wiki is organized. A definite bookmark if you’re into social media in our space. Brand Sponsored Patient Communities Patient Communities (Non-Brand Sponsored) Physician and Nurse Communities Facebook YouTube Twitter (Pharma &… -
Data, data, data
3 Dec 2009 | 4:13 amFacts, figures, data. We all love to use numbers in our PPTs. Great info has trickled out over the past couple of months from one of my favorite sources – Manhattan Research. And thank you to MR for mentioning Pharma 2.0 in its white paper: How Digital is Shaping the Future of Pharmaceutical Marketing. There are far more pharma/social media blogs out there today than there were when I started last year. Patients Over 102 million people are using the Web to research prescription drug information. Over 157 million consumers are using the Web to research any health or medical info. About…
- BeyeNETWORK Biopharma Channel
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Tom Coffing, Coffing Data Warehousing
8 Feb 2010 | 6:00 amTom Coffing explains how the Nexus allows business and technical users to integrate data across all databases. -
Mark Cunningham, Indicee
2 Feb 2010 | 6:00 amMark Cunningham discusses how Indicee provides a faster way to create reports, for people who are frustrated with cutting and pasting data into spreadsheets - users with no IT expertise, can combine data and set up reports in minutes by accessing Indicee’s online service. -
Ken Bero, Datawatch
14 Jan 2010 | 6:00 amKen Bero discusses how Monarch V10.5 allows users the ability to create and export Microsoft Office Excel spreadsheets containing the original source of the data—eliminating spreadsheet-induced uncertainty, reducing the audit cycle and easing compliance. -
Sybase IQ Delivers Query Performance for Complex Analytics Tasks
11 Jan 2010 | 6:00 amExclusive interview featuring Sybase’s Joydeep Das -
Joydeep Das, Sybase
11 Jan 2010 | 6:00 amJoydeep Das discusses how Sybase IQ is a highly optimized analytics server designed specifically to deliver faster results for mission-critical business intelligence, data warehouse and reporting solutions on any standard hardware and operating systems.
- S&R Blog
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Which industry’s ads are most trusted by Americans?
8 Feb 2010 | 11:49 amIf you answered pharma, then you’re right when compared only to the financial industry. But according to a new poll conducted by Harris Interactive and AdweekMedia, when compared to the soft drink, fast food, and auto industries, pharmaceuticals ads come in as least trustworthy by Americans. Of the five industries about which the poll inquired, soft drinks had the highest “most trustworthy” vote (34 percent) and the lowest “least trustworthy” score (4 percent). Fast food was the runner-up in both respects (22 percent “most trustworthy,” 10 percent… -
Why Pharma Is Pushing Its Drug Pushers Out
28 Jan 2010 | 12:54 pmNew day. Same story. Source:Minyanville The pharmaceutical industry is going through a transformation — not only has it been consolidating with mega-mergers like the one between Merck (MRK) and Schering-Plough, but it’s facing a major patent cliff as the revenues from the blockbuster drugs of the 1990s fall prey to generic competition. Yet, these larger changes have led to shifts in other parts of the industry, too. Since Big Pharma can no longer rely on new blockbuster drugs to pad their top line, these companies now have to transform how they do business to include the biotech model… -
What do physicians really think about Big Pharma?
21 Jan 2010 | 12:04 pmAccording to Dr. Candida Fink’s latest blog post on PsychCentral, not highly. In what clearly wasn’t a good year for pharma in terms of reputation, Dr. Fink highlights why she will “no longer see any drug reps.” I didn’t want to hear from them, and I haven’t since. I avoid lectures and meetings that drug companies sponsor, and I use no drug company pens or notepads. The longer I avoid direct contact with drug company reps, the better I feel about it. The further removed I am from these things the more I realize I was getting a lot of my information about… -
Will medical education help to fill the credibility gap in pharma?
13 Jan 2010 | 11:08 amDavid H. Recht of North State Resources Inc. and Kelli Soare and Ed Leon of S+R Medical Communications discuss how credible, needs-based branded medical education can help to make the pharmaceutical industry a trusted resource for physicians once again. Source: Med Ad News Recognizing the erosion of trust physicians have in the information they receive from the pharmaceutical industry, the healthcare advertising agency S&R Communications Group has recently re-engineered into two specialized companies, S+R Medical Communications and Friday Morning. Friday Morning will provide insight on a… -
Will the Mac Tablet revolutionize EMRs?
7 Jan 2010 | 1:48 pmAfter a lull of about 6 months the Mac Tablet buzz has started to heat up again with Apple announcing its release for March. Like the iPhone before it, the medical community has started to hail the Mac Tablet as a revolutionary healthcare device, most notably for electronic medical records (EMRs). Ease-of-use has been a primary barrier to EMR adoption, so Apple – known for intuitive design and usability – would be welcomed by physicians. The EMR possibilities for the Mac Tablet have been covered in depth through an article at Softwareadvice. “The Ultimate EMR User Interface An…
- Dose of Digital
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Monitor This, Forget That — “The Monitoring Continuum”
9 Feb 2010 | 6:00 amOne of the most contentious posts ever on Dose of Digital was my post about social media monitoring for pharma and healthcare. The title alone was enough to set some people off: Pharma Should Forget About Social Media Monitoring. The point of that post was not that everyone should truly forget about monitoring, but that they should forget about it if they don’t plan on doing anything with what they find. In other words, if you’re not going to respond to discussions or don’t have a FORMAL plan to use what you find in some research setting (presumably to inform some brand… -
The Seven Uses of Social Media in Business — The 7 “C”s
3 Feb 2010 | 10:31 amWhether it be healthcare or any other industry, different companies have come up with and rely on different uses of social media to meet their brand objectives. After surveying a bunch of different social media programs (including the hundreds found on the Pharma and Healthcare Social Media Wiki), I figured out that for the nearly infinite number of final executions, there are really only seven distinct uses of social media in business. Seven might sound like a lot, but it’s nothing compared to the number of channels within social media from Facebook to Wordpress to Flickr to Foursquare… -
The Best Pharma Products According to Patients
1 Feb 2010 | 8:08 amUPDATE (Feb. 2, 2010): Based on some feedback from none other than John Mack, I’ve changed a couple of pieces of info from my original post, as well as some insights from iGuard about how they conduct their surveys. This can be found at the bottom of this post.] On a couple of occasions, I’ve talked about the potential impact of having product reviews for pharma products (see “Why Pharma Needs Product Reviews” and “One more Reason Pharma Needs Product Reviews“). You can check out those posts to see my rationale for why pharma might benefit from having… -
How Google and Bing Plan to Eliminate the Need for WebMD (and Your Website)
25 Jan 2010 | 8:33 amThose of you who are regular readers know that I’m a big believer in search optimization. In most cases, it’s the single most powerful way to expose the right people to your brand at the right time. The importance of search as it relates to our digital lives is pretty significant. Consider this: 80% of all online sessions begin with search. Google has a 63.7% share of all searches. The point? Most people find things online by sitting down and using a search engine. It’s the first thing that happens 80% of the time. Two thirds of the time, these people are using Google. That… -
Social Media in Pharma and Healthcare 2010: First Wiki Update of the Year
22 Jan 2010 | 6:36 amFor those of you who are really interested in social media in pharma and healthcare, 2009 was a banner year for you. Literally hundreds of new programs were launched, as companies became more comfortable with the idea that it’s possible to use social media in pharma and healthcare. I like to think a very tiny bit of the credit for the creation of so many programs goes the Pharma and Healthcare Social Media Wiki. Why? As I’ve heard from many people, the wiki serves as a great place to show precedent. When your legal team or CEO balks at the idea of doing anything in social media,…
- BioPharma Today
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Coming in Wednesday's "The Pink Sheet" DAILY
9 Feb 2010 | 9:28 amAfter a snow delay, ChemGenex will have more time to prepare for what may be a challenging review of Omapro (omacetaxine mepesuccinate) for chronic myeloid leukemia by FDA's Oncologic Drugs Advisory Committee - Updates from the BIO CEO & Investor conference -
Chugai, Achillion, China's ADR Reporting Problem - Latest From PharmAsia News
9 Feb 2010 | 8:48 amChina grapples with ADR reporting problems -- Chugai sets records results in 2009 -- Achillion sends HBV, HIV treatment elovucitabine to China -
"The Pink Sheet" Outlines Key Factors In The Fate Of Amgen's Osteoporosis Drug Denosumab.
9 Feb 2010 | 8:30 amAnalysts at "The Pink Sheet," have recently delivered penetrating analysis of an important new drug. "The Pink Sheet" reports on critical elements in this process, from the inside debate among approval committee memebers to the unusual makeup of the committees and their reputations for rigorouse standards. Download our complimentary analysis free -- Today! -
Have You Joined Our LinkedIn Group Yet?
9 Feb 2010 | 7:15 amIf you belong to LinkedIn, we would like to invite you to join a new group we have launched for BioPharma Today. -
What’s in Your Pipeline? The Feds Want to Know
9 Feb 2010 | 7:06 amThe Agency for Health Care Research & Quality (the US government's de facto comparative effectiveness research center) is slowly but surely funneling out its portion of the $1.1 billion in stimulus money set aside for comparative effectiveness research last year.
- TradePub: Pharmaceuticals
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eHealth SmartBrief
1 Feb 2010 | 4:50 pmeHealth SmartBrief brings you the health care information technology news that really matters. Their editors handpick and summarize key articles from hundreds of publications and provide links back to the original sources. By providing a summary of the most important health care and technology news, eHealth SmartBrief saves you time and keeps you smart.Sign up today to receive eHealth SmartBrief, FREE of charge.Request Free! -
PMP News.com Daily Newsletter
1 Feb 2010 | 9:20 amPMP News.com Daily Newsletter is produced by the editors of Pharmaceutical & Medical Packaging News and subscribers will be able to forward the e-newsletter easily to share breaking developments with colleagues.Request Free! -
Pharmaceutical Executive
1 Feb 2010 | 12:20 amWhen pharmaceutical decision makers need news and insights about pharma's future and how to respond to it, they turn to Pharmaceutical Executive magazine. From strategy to marketing to the best new ideas about sales, R&D, regulations, finance, meetings and IT, Pharmaceutical Executive covers it all.Request Free! -
Bio-IT World
1 Feb 2010 | 12:20 amBio-IT World, the flagship publication of Cambridge Healthtech Institute (CHI), is the leading source of news on technology and strategic innovation in drug discovery, development, and clinical trials. Bio-IT World explores the tools and results of predictive biology as the industry adapts to the new world of personalized medicine. The magazine focuses on key technologies that shape the life sciences industry--high throughput sequencing, pathway analysis, adaptive clinical trials, the Semantic web, biomarkers, in silico screening, high performance computing, and much more. Expert views from… -
Biotechnology Healthcare
1 Feb 2010 | 12:20 amIts editorial mission is to articulate biomedical business and clinical applications to healthcare decision makers and stakeholders. A strict fact-checking and peer review process assures the accuracy and relevance of editorial content.Request Free!
- Pharma QbD
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PAT and QbD for Biopharmaceuticals
4 Feb 2010 | 1:30 pmDate: 05/25/2010 End: 05/26/2010 Timezone: Developing a secure in-house strategy for PAT and QbD application for biopharmaceutical products. read more -
Design for Six Sigma: A Potent Supplement to QbD
26 Jan 2010 | 10:47 amThe tools of Design for Six Sigma help development teams to find the “vital few” and build on the strengths of Quality by Design. read more -
2010 PDA/FDA Joint Regulatory Conference
14 Jan 2010 | 2:38 pmDate: 09/13/2010 End: 09/15/2010 Timezone: The PDA/FDA Joint Regulatory Conference offers the unique opportunity for you to join FDA representatives and industry experts in face-to-face dialogues. read more -
2010 PDA Annual Meeting
14 Jan 2010 | 2:34 pmDate: 03/15/2010 End: 03/19/2010 Timezone: Join industry and regulatory peers at this meeting to examine manufacturing best practices and strategies to maximize your company’s efficiency and productivity, while delivering safe and reliable drugs to patients. read more -
Spare Parts: Waters Releases 2010 Supplies Catalog
14 Jan 2010 | 10:28 amThe catalog includes listings of quality parts, chromatography columns, and other key supplies. read more
- Adpharm pharmaceutical advertising intelligence
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Image Metrix - unlock
9 Feb 2010 | 9:43 am -
Advair - time
9 Feb 2010 | 2:23 am -
Let's talk RA - Kristi
9 Feb 2010 | 2:23 am -
Bayer 81 - reasons why
9 Feb 2010 | 2:23 am -
Lucentis - preserved
8 Feb 2010 | 5:32 pm
- AdPharm Blog
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Saphris – pages 2 and 3 of 8
9 Feb 2010 | 8:03 amClick here for the full-sized ad and details in the gallery This ad and thousands more can be seen on the AdPharm gallery, the largest keyword searchable online pharmaceutical advertising gallery. -
Prodigy Pocket – being myself
9 Feb 2010 | 8:03 amClick here for the full-sized ad and details in the gallery This ad and thousands more can be seen on the AdPharm gallery, the largest keyword searchable online pharmaceutical advertising gallery. -
Prodigy AutoCode – better control
9 Feb 2010 | 8:03 amClick here for the full-sized ad and details in the gallery This ad and thousands more can be seen on the AdPharm gallery, the largest keyword searchable online pharmaceutical advertising gallery. -
Bekol – Bubble project
9 Feb 2010 | 8:03 amClick here for the full-sized ad and details in the gallery This ad and thousands more can be seen on the AdPharm gallery, the largest keyword searchable online pharmaceutical advertising gallery. -
cancer-test.de – cervical
9 Feb 2010 | 8:03 amClick here for the full-sized ad and details in the gallery This ad and thousands more can be seen on the AdPharm gallery, the largest keyword searchable online pharmaceutical advertising gallery.
- Pharmaceutical Online
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User Intuitive X-ray Inspection System For Increased Uptime
9 Feb 2010 | 1:23 amSmartChek X-ray inspection is an ideal solution for cost-effective inspection of small packaged products to protect your brand. SmartChek delivers the highest detection sensitivities without the complexities typically associated with X-ray inspection with the Mettler-Toledo Safeline hallmark qualities of accuracy, reliability, and ease of operation. -
Mettler-Toledo CI-Vision Introduces A White Paper Entitled 'What Machine Vision Can Do For You'
9 Feb 2010 | 12:22 amMettler-Toledo CI-Vision, the leader of vision systems, has produced a white paper outlining the features and benefits of vision systems for food production lines. The document explains how machine vision works and how the technology has improved over time. -
AnaptysBio Announces Strategic Collaboration With Merck & Co., Inc.
8 Feb 2010 | 7:00 amAnaptysBio, Inc., a privately-held therapeutic antibody platform and product company, today announced a strategic collaboration with Merck, through an affiliate, to develop novel antibody therapeutics to a specified disease target. -
Teva Acquires Marketing Rights For Oral Laquinimod In The Nordic And Baltic Regions
8 Feb 2010 | 5:30 amTeva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today that they have amended the marketing and distribution agreement for oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS). -
Abbott Submits New Automated Ovarian Cancer Test For U.S. Approval
8 Feb 2010 | 1:53 amA new diagnostic tool physicians can use to monitor patients for the most common form of ovarian cancer may soon be available in the United States.
- Bioresearch Online News
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Novavax Reports Additional Positive Data From Its Trivalent Seasonal Influenza (VLP) Vaccine Clinical Study In Healthy Adults
7 Feb 2010 | 11:16 pmNovavax, Inc. (Nasdaq: NVAX ) announced today new data from a clinical study that began in May of 2009 among healthy adults 18 to 49 years of age with Novavax's trivalent seasonal influenza Virus-like Particle (VLP) vaccine. -
Lupin Receives FDA Approval For Amlodipine/Benazepril Capsules
7 Feb 2010 | 10:05 pmLupin Pharmaceuticals, Inc. announced recently that the U.S. Food and Drug Administration (U.S. FDA) has granted final approval for its Amlodipine/Benazepril 2.5mg/10mg, 5mg/10mg, 5mg/20mg and 10mg/20mg capsules. -
Novozymes Signs Agreement With ProMetic For Albumin Purification Technology
4 Feb 2010 | 10:15 pmNovozymes A/S, a Denmark-based biotechnology company, and ProMetic Life Sciences, Inc., a Canada-based biopharmaceutical company, have entered into a strategic agreement regarding proprietary albumin purification technology based upon a synthetic-ligand affinity adsorbent developed by ProMetic's UK subsidiary, ProMetic BioSciences, Ltd. -
Calibration Free Supersaturation Assessment and Control For The Development And Optimization of Crystallization Processes
4 Feb 2010 | 6:24 amIn this webinar, a method will be presented which facilitates the calibration free use of in situ ATR-FTIR spectra for the production and control of qualitative supersaturation trajectories. -
Mirrx Therapeutics A/S Secures Seed Financing For Development Of Novel MicroRNA-Blocking Technology
4 Feb 2010 | 6:17 amMirrx Therapeutics today announced that it has closed on a seed financing round that will enable the company to achieve in vivo proof of concept for its microRNA-blocking "Blockmir" technology, as well as to strengthen its intellectual property portfolio.
- PharmiMike
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Gatszu’s “Recruitment Revolution”
8 Feb 2010 | 7:21 amGatszu.com is claiming to be a fast and transparent recruitment solution and the start of a new revolution… The online recruitment marketplace that connects employers seeking talent to approved recruiters across the UK Launched in February 2010, gatszu.com, in association with The Sunday Times HR Business Network, is an online recruitment marketplace that connects employers seeking high quality candidates to specialist recruiters in the UK. Giving employers the opportunity to set their own fixed fee, centralise their recruitment process and gain access to a far wider pool of talent… -
Its like Twitter, only better…
29 Jan 2010 | 8:26 amI came across this today http://twitiq.com/ its a twitter “client”, that allows you to manage your Twitter account though an interface that is like Twitter only better. You can have multiple twitter accounts, and manage them quite well. You may prefer tweetdeck, but I think this is quite neat. No related posts. -
Back from Christmas
13 Jan 2010 | 12:53 pmI’m back from Christmas and from snowboarding in the Alps – getting used to all this snow at home now! Even managed to have a snow kiting (snowboard and kitewing) session a couple of miles from my house at the weekend. Brilliant. Related posts:Snowboarding with concrete cows? At last, Twitter is useful! #UKsnow -
At last, Twitter is useful! #UKsnow
22 Dec 2009 | 1:33 amMy plan was to go to the office in Bracknell this morning, but I was getting horror stories from office colleagues who were abandoning their cars and taking hours to get home. Looking at the BBC website – nothing – no news. What we need is something more immediate, to tell us where the snow has got to, so we can map it. Well its already done.. http://uksnow.benmarsh.co.uk/ Using tweets with #UKsnow and followed by the first 4 digits of your postcode, twitterers can indicate where it’s snowing – in real time, and indicate the severity. Clever Ben Marsh then plots it… -
Keep your sitemaps up to date
26 Nov 2009 | 8:04 amThis may seem obvious, and also more of an SEO point, but as I’ve just spent some time doing it myself, I thought I’d remind you!. Google et al, rely heavily on sitemap.xml to know what’s on your site. Sure they can crawl and do crawl it, but why make their lives hard. By keeping a valid sitemap.xml file in the root of your site, you provide a link to all the pages on your site that the search engines should know about. A few points: you should update your sitemaps every time you change content. (ie add a new job) so it should be done dynamically without you having to…
- Pharma News from PharmiWeb.com
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Quintiles Again Named to Training Top 125, for Workforce Training and Development Excellence
8 Feb 2010 | 5:00 pmQuintiles Again Named to Training Top 125, for Workforce Training and Development Excellence Quintiles, the world’s...Quintiles -
Extreme Weather in Washington D.C. has Postponed the FDA’s Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010
8 Feb 2010 | 5:00 pmExtreme Weather in Washington D.C. has Postponed the FDA’s Oncologic Drugs Advisory Committee Meeting Scheduled for 10 February 2010 -
Cosmo Pharmaceuticals announces preliminary interim result of its tender offer for BioXell
8 Feb 2010 | 5:00 pmCosmo Pharmaceuticals announces preliminary interim result of its tender offer for BioXell Lainate, Italy, 9 February 2010 ...Cosmo Pharmaceuticals -
Solianis Monitoring AG on its Way to Success - Market Entry as Planned in 2011
7 Feb 2010 | 5:00 pmSolianis Monitoring AG on its Way to Success - Market Entry as Planned in 2011ZURICH, February 8 /PRNewswire/ -- Solianis Monit...Solianis Monitoring AG -
NICE welcomes topic suggestions for QOF
7 Feb 2010 | 5:00 pmNICE welcomes topic suggestions for QOF The National Institute for Health and Clinical Excellence (NICE) has today (Monday 8...NICE
- Pharmaceutical Business Review
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Dow Reports Increase In Q4 Sales
3 Feb 2010 | 10:30 pmDow has reported a net income from continuing operations of $178m for the fourth quarter of 2009, compared to the net loss from continuing operations of $1.55 billion in the fourth quarter of 2008. -
Siegfried To Create Functional Organization
1 Feb 2010 | 10:30 pmSiegfried Group will be introducing a functional organization to replace its current two-division structure, effective March 1, 2010. The new structure is a result of strategic adjustments approved in the summer of 2009. Siegfried will increasingly market its two core capabilities, namely the development and production of active pharmaceutical ingredients and finished dosage forms, as a single package. -
Lanxess To Establish New Formalin Facility In Germany
1 Feb 2010 | 10:30 pmLanxess is planning to establish a new facility for formalin production at its site in Krefeld-Uerdingen, Germany. The specialty chemicals group will then no longer be dependent on buying in the feedstock, which it needs for the production of trimethylolpropane (TMP). -
Braskem Takes Over Sunoco Chemicals
31 Jan 2010 | 10:30 pmBraskem, a resin producer in the Americas, has signed an agreement with Sunoco wherein the former acquires the polypropylene (PP) business of Sunoco Chemicals. Sunoco will receive $350m for the shares in Sunoco Chemicals (PP assets), upon closing, within 60 days. -
Actavis Divests Norgesplaster
31 Jan 2010 | 10:30 pmActavis has sold Norgesplaster, its manufacturing facility for plasters and athletic tape and adhesive coating, in Vennesla, Norway, to a newly formed entity, Norgesplaster AS. Norgesplaster AS is a legal entity owned by private Norwegian investors. The transaction covers all assets and contracts related to Norgesplaster.
- EuroPharma Today
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GSK Argues Its Strategy Is Delivering As Still More Cuts Are Made, Including in R&D
4 Feb 2010 | 11:33 pmGlaxoSmithKline CEO Andrew Witty declared on Feb. 4 that his strategy of building a global, diversified business was delivering. And to prove his point, he announced a return to full-year sales growth in 2009 after a negative 2008, and an upbeat forecast for 2010 as well. -
Austria's Apeiron Wins £11m GSK Respiratory Deal
4 Feb 2010 | 3:34 amPrivately-owned Austrian biotech Apeiron on Feb. 3 attracted £11 million ($17.5 million) in upfront cash and equity from GlaxoSmithKline for full rights to its Phase I biologic for acute respiratory distress syndrome (ARDS). The deal signals GSK's continued interest in accessing compounds that address challenging and often specialist areas. ARDS affects about 1 million people per year in developed markets (an incidence roughly similar to that of colon cancer). But it isn't a primary event - ARDS is associated with a range of complex conditions such as sepsis, trauma and post-operative… -
Cephalon Buys Swiss Generics Firm Mepha, Talking Up Diversification
2 Feb 2010 | 3:37 amIn a move that seems like an about face for a specialty pharma, Cephalon announced plans on Feb. 1 to buy the Swiss generics maker Mepha, citing international expansion and portfolio diversification. Under the arrangement, Cephalon will pay CHF 622.5 million ($590 million) in cash to the Merckle family-owned Mepha Holding AG. -
Europe Matters, says Cephalon, with $590m Mepha Deal
1 Feb 2010 | 12:15 pm"Europe hasn't been high-profile for a lot of you" [mostly US analysts], declared Cephalon's Chairman & CEO Frank Baldino, "but it should be." As a European-based (and minded) reporter, that was my favorite--whoops, should I say favourite--quote from the conference call today annoucing Cephalon's CHF 622 million ($590 million) cash... -
European Switch Progresses, But Stronger Incentives Needed For OTCs
1 Feb 2010 | 3:37 amEurope needs to provide more incentives for consumer firms, otherwise the OTC industry will "make commercial decisions" that could reduce their presence in the area, suggested Manfred Scheske, Glaxo-SmithKline's Consumer Healthcare Europe president and VP of the Association of the European Self-Medication Industry, speaking at that organization's meeting in London Jan. 20.
- Medical-Brochures.blogspot
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Smoking Cessation
7 Feb 2010 | 1:34 amCopy writing : It smells different to non-smokers. Artwork & Concept: It's really a so "smelly" new idea, it show the cigar as a piece of "shit". Ref.: www..azur.com.au for training ! Please... http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions. -
How to become a pharmaceutical sales person
5 Feb 2010 | 11:46 amHow to Become a Pharmaceutical Salesperson -- powered by eHow.com http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions. -
Top 10 health care social media predictions for 2010
4 Feb 2010 | 1:02 pmSocial media has been the dancing elephant in the living room of medical marketing ever since user-generated content on the Web became possible, and the furniture hasn’t stopped shaking since. But... http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions. -
Anti-Smoking Campaign
4 Feb 2010 | 11:37 amAgency: Team Young & Rubicam, Abu Dhabi Art Director: Krishnagopal Kodoth Copywriter: Mohit Raviranjan, Kaushik Bhattacharya Graphic artist: Srinivas Sarma Executive Creative Director: Trevor... http://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions. -
Spimaco's Snafi
4 Feb 2010 | 9:22 amhttp://medical-brochures.blogspot.com/ the Pharmaceutical Archive of Medical Brochure s, Artwork Designs and Advertisements; to serve Pharmaceutical Marketers, Product Managers, Sales Managers, Medical Representatives, Doctors of different specialties and other Medical Professions.
- Impactiviti
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Pharma eMarketing Roundup 020510
5 Feb 2010 | 6:45 amIt’s that time again – a quick collection of links of interest for pharma marketers who are tracking the eMarketing and Social Media space. Here we go: What’s the Point of Health 2.0? (Path of the Blue Eye project), in which Fard Johnmar expands on Susannah Fox’s thoughts. Also, for the same blog – What Good is Social Media Transparency? The Seven (soon to be Nine) Uses of Social Media in Business. From the thoughtful and prolific Jon Richman. New web 2.0 site from Hungary: ScienceRoll Social Media Forums and the Pharma Industry, from eyeforpharma. Fascinating… -
Impactiviti Daily 020510
5 Feb 2010 | 5:42 amNEXT WEEK: IIRUSA’s ePharma Summit, Philadelphia, PA. I’ll be there, reporting live via social media. You? TODAY’S NEWS Untreated, minor depression may well lead to major depression. Coming: “artificial pancreas” technology for treatment of Type 1 diabetes? Pretty cool! Good to know – Astelin is not indicated as a cure for house cleaning! How a pharma company can get skewered by analysts for fudging numbers. RECOMMENDED Compliance training – Sales reps, internal folks – everyone needs some level of compliance training. And Impactiviti’s business partners… -
Virtual World-ing
5 Feb 2010 | 4:57 amRecently, I attended a gathering to discuss training applications in virtual worlds. If you know me, you know I love technology, and I’ve always been interested in how technology can transform training and marketing. One area I’ve always tracked is 3-D virtual worlds. My sense, for years, has been that it’s just not ready for prime-time in a broad sense. Like many others, I see the potential, I see the “cool” factor – but I often do not see a compelling business application. Most regular folks (not techno-geeks) may find it rather difficult learning to… -
Impactiviti Daily 020410
4 Feb 2010 | 6:43 amNEXT WEEK: IIRUSA’s ePharma Summit, Philadelphia, PA. I’ll be there, reporting live via social media. You? TODAY’S NEWS AstraZeneca looking down the barrel of 26,000 Seroquel lawsuits. Or so. New treatment for debilitating hand condition – The Food and Drug Administration Tuesday approved the first drug designed to treat a debilitating hand condition known as Dupuytren’s contracture. The drug, called Xiaflex, is manufactured by Auxilium Pharmaceuticals Inc. of Malvern, Penn., and the company expects to begin selling it by the end of March. An FDA advisory panel in… -
Impactiviti Daily 020210
2 Feb 2010 | 8:32 amTODAY’S NEWS Keep some Lexapro around for strokes. Forest Laboratories Inc.’s antidepressant Lexapro may help stroke patients recover some of their mental skills, a study said. Patients who took Lexapro recovered more of their visual and verbal memory after 12 months of treatment than those given a placebo or those who underwent therapy without drugs, researchers reported today…more Will there be a new dementia treatment coming? – Doctors may learn next month that Dimebon, a 27-year-old hay fever treatment and one of the most mysterious compounds yet tried to fight dementia,…
- Hooked: Ethics, Medicine, and Pharma
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Another County Heard From: An ACRE Perspective on Conflict of Interest and 'Political Correctness'
9 Feb 2010 | 10:42 amOn a few occasions I have mentioned my colleague Dr. Avi Markowitz, chief of medical oncology at our medical center. Dr. Markowitz recently presented a Cancer Center Grand Rounds on “Academia and Industry.” As he’s a member of the Board of Directors of the Association of Clinical Researchers and Educators (ACRE), this talk promised to be a good summation of the position that I have opposed in this blog. I thought that a good way to present the ideas is to try to restrain myself and give Dr. Markowitz’s point of view as much as possible, perhaps then devoting a subsequent post to a… -
Ghostwriting: Academic Medical Centers Need to Step Up
9 Feb 2010 | 10:00 amIn HOOKED I referred to ghostwriting of medical journal articles as "a particularly egregious ethical violation" but said little about what should be done about it. Our friends Jeffrey Lacasse and Jonathan Leo have made up the deficiency nicely:http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000230Lacasse and Leo began by searching the on-line policies (and contacting staff at the medical school if policies were unavailable on line) for the 50 highest ranking medical schools in the US according to US News and World Report. They were able to identify policies… -
HOOKED among Top 50 Public Health Blogs
7 Feb 2010 | 2:15 pmI am posting this link to an article listing the Top 50 blogs on public health not just to brag about this blog making the list, but also since readers might be interested to know what other blogs are available on these important topics:http://mastersinhealthscience.com/2010/top-50-public-health-blogs/ -
India on Gifts to Docs: Just Say No
25 Jan 2010 | 7:28 amThe following item came my way courtesy of the Healthy Skepticism list-serv and as the material itself is labeled for public release, I asume I have permission to post it here. It suggests yet a further way in which India may be ahead of the U.S. I have bolded what I take to be the key messages below.****The following editorial will appear in the Monthly Index of Medical Specialities, New Delhi, India in its January 31, 2010 issue. Released in advance for public information.Indian Medical Council Defines Do's and Don'ts for DoctorsExtensive media coverage of the unethical,… -
DOJ: Johnson and Johnson Paid Big Kickbacks to Push Risperdal in Nursing Homes
15 Jan 2010 | 7:30 pmFor background, start with Ed Silverman's post on Pharmalot: http://www.pharmalot.com/2010/01/johnson-johnson-charged-with-kickback-scheme/Then go to the DOJ press release (1 page): http://www.justice.gov/opa/pr/2010/January/10-civ-042.htmlThen finally if you want all the details go to the actual complaint (34 pages): http://freepdfhosting.com/e4fd147775.pdfBased on whistleblower disclosures, the Feds are charging Johnson & Johnson with paying tens of millions of dollars in illegal kickbacks to Omnicare, a pharmacy management company that deals with nursing homes, to promote the use of…
- FDA Law Blog
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Recent Rulings Once Again Shine the Light on Sham Citizen Petition Antitrust Issues
9 Feb 2010 | 10:09 amBy Kurt R. Karst – Two recent rulings out of the U.S. District Court for the Eastern District of Pennsylvania stemming from allegations about antitrust violations from the submission of citizen petitions have once again raised the issue of so-called “sham” citizen petitions and, insofar as there are allegations of violation of Section 2 of the Sherman Act, Noerr-Pennington immunity. In each case – In Re: Flonase Antitrust Litigation and Roxane Laboratories v. Smithkline Beecham – the plaintiffs allege that GlaxoSmithKline, Inc. (“GSK”) submitted a series of… -
HPM Attorney to speak at ACI Pharma Advertising Conference
8 Feb 2010 | 11:51 amHyman, Phelps & McNamara's Jeffrey N. Wasserstein (co-chief blogger at fdalawblog.net and self-described social media guru) will be speaking on the regulation of social media at the American Conference Institute’s 8th Expert Regulatory Guide to Advertising, eMarketing and Promotions for the Pharmaceutical Industry, taking place in the City of Brotherly Love, (that's Philadelphia, PA) from April 14-April 15, 2010. Registration materials for the conference can be found here. Loyal readers of the blog may obtain a $200 discount by using discount code 876L10.S. -
Has FDA Already Resolved One Critical Issue Concerning Forced Rx-to-OTC Switches?
8 Feb 2010 | 8:39 amBy Kurt R. Karst – FDA’s ability to force a prescription-to-over-the-counter switch (“Rx-to-OTC switch”) has been hotly contested over the past decade. The crux of the debate concerning forced Rx-to-OTC switches is whether FDA, absent a New Drug Application (“NDA”) sponsor’s consent, has the authority to force an Rx-to-OTC switch; and if so, on what legal basis. (Although FDA attempted a forced switch once – almost 30 years ago – when the Agency proposed to switch metaproterenol sulfate metered-dose inhaler drugs from Rx to OTC status under the OTC Drug… -
Stipulation of Dismissal in Winston Laboratories Small Business User Fee Waiver Case
3 Feb 2010 | 11:58 amBy Michelle L. Butler – This week, the parties in the Winston Laboratories case filed a Stipulation of Dismissal with Prejudice Pursuant to Fed. R. Civ. P. 41(a). This case involved FDA’s interpretation of the term “affiliate” in its decision to deny Winston a small business waiver of the PDUFA fee for a new drug application. Given the Court’s prior decision denying the Government’s Motion to Dismiss, it is likely that the parties settled the case on terms favorable to Winston. We do not yet know how FDA will deal with similar small business waiver determinations going… -
All for One and One for All – FDA Denies Graceway Petition on Generic ALDARA Cream
3 Feb 2010 | 11:57 amBy Kurt R. Karst – Late last month, FDA denied a citizen petition submitted by Graceway Pharmaceuticals, LLC (“Graceway”) requesting that the Agency refuse to approve Abbreviated New Drug Applications (“ANDAs”) for generic versions of Graceway’s ALDARA (imiquimod) Cream, 5%, unless such applications contain, among other things, data from bioequivalence studies conducted in patients with each of ALDARA’s approved conditions – actinic keratoses (“AK”), primary superficial basal cell carcinoma (“sBCC”), and external genital and perianal warts/condyloma…
- PHARMACOSERÍAS Marketing Farmacéutico/Pharmaceutical Marketing
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PRECIOS: Por qué...?
8 Feb 2010 | 3:05 pmHealth Action International (HAI) publica en Internet los resultados de un "vistazo" mundial a los precios de un tratamiento de 7 días con Ciprofloxacina 500 mg, comparando el producto "original" (CIPRO® de Bayer en Colombia) y el medicamento "genérico" -
Pfizer: "Apenados por el pene" al fin les reconocen...
8 Feb 2010 | 3:04 pmEstaban (Pfizer) "apenados" por el problema del pene y... "buscaron remedio", fuera porque en "casa" no había...Lo lograron...Se lo reconocieron...Al fin y al cabo..."Extensión de línea".The FDA today approved Auxilium´s Xiaflex drug for Dupuytren’s contracture. Or, to translate that into language a layperson would be interested in: The FDA today approved Pfizer´s penis-straightening drug for a -
DTC/DTP/DTJ (VI) o de... "me lo ha mandado el médico" a "me lo ha mandado el paciente"
8 Feb 2010 | 3:03 pmVer...Ver anteriores... -
De " promesa" a realidad...(?): Pipeline (II)
8 Feb 2010 | 3:02 pmAsmaDiabetesVer anteriores -
Ponte al día con Fierce Pharma...
8 Feb 2010 | 3:01 pm<!--[if gte mso 9]> Normal 0 21 false false false ES X-NONE X-NONE MicrosoftInternetExplorer4 <![endif]--><!--[if gte mso 9]>
- Beck on Biotech
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Iron Safety Hits AMAG Pharmaceuticals
4 Feb 2010 | 10:53 amShares of AMAG Pharmaceuticals, Inc. (AMAG) traded as low as $37.70 today, down nearly 17% from the prior close of $45.25 due to purported safety concerns regarding Feraheme® [ferumoxytol], the company’s marketed product for the treatment of iron deficiency anemia [IDA] in adult patients with chronic kidney disease [CKD]. Despite the use of recombinant erythropoietin, anemia remains a significant problem for patients with CKD and end-stage renal disease [ESRD]. As such, parenteral iron formulations in conjunction with erythropoietin have become standard practice. Iron replacement therapy… -
Biotech Deal Activity Declines…The Pause that Refreshes?
14 Jan 2010 | 7:54 pm* MD Becker Partners reporting live from the JP Morgan Healthcare Conference This week, nearly 6,500 registrants gathered in San Francisco, California for the JP Morgan Healthcare Conference to hear 25-minute presentations from 338 life science companies. For industry executives and investors, the annual event serves as a good barometer for the rest of the year. We roamed the familiar halls of the Westin St. Francis Hotel to assess the mood among participants and also monitored online media commentaries throughout the event. In general, there was a flurry of activity, the plane flights… -
2009: Biotech’s Stealth Small Cap Rally
3 Jan 2010 | 5:58 pmOn the heels of the Dow Jones Industrial Average (DJIA) logging its worst annual performance since 1931 and the NASDAQ Composite (COMP) having its worst year since inception in 1971, it may have seemed counter intuitive to provide a bullish outlook for the biotechnology industry in 2009. Nonetheless, at the start of the year we provided a positive outlook for biotechnology, citing the sector’s defensive characteristics, favorable technical aspects, and improving fundamentals, such as the number of new product approvals, products in clinical trials and the brisk pace of industry… -
Graft Versus Host Disease: Failures and Future Opportunities
9 Dec 2009 | 4:17 pmIn September 2009, Osiris Therapeutics, Inc. (OSIR) reported preliminary results from two Phase III trials evaluating its Prochymal product candidate for the treatment of acute Graft-versus-Host disease [GVHD]. Unfortunately, neither trial reached its primary endpoint, sending shares from $14 to a 52-week low of $5.35 by November 2009. The results were the latest in a number of late-stage, clinical trial setbacks for the treatment of GVHD [see table 1], prompting us to review this very complicated disease in search of future treatment opportunities. What is GVHD? When a cancer patient… -
Buyout Buzz at ASH Hematology Confab
7 Dec 2009 | 6:52 amScientific and medical advances weren’t the only topic of discussion at the 51st American Society of Hematology [ASH] Annual Meeting that began over the weekend in New Orleans, LA, as merger and acquisition activity took center stage. Early this morning, Celgene Corporation (CELG) announced the acquisition of privately-held Gloucester Pharmaceuticals for $340 million in cash plus another $300 million in future U.S. and international regulatory milestone payments. Gloucester’s Istodax® (romidepsin) was approved in November 2009, by the U.S. Food and Drug Administration [FDA] for the…
- Beck on Biotech
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Iron Safety Hits AMAG Pharmaceuticals
4 Feb 2010 | 10:53 amShares of AMAG Pharmaceuticals, Inc. (AMAG) traded as low as $37.70 today, down nearly 17% from the prior close of $45.25 due to purported safety concerns regarding Feraheme® [ferumoxytol], the company’s marketed product for the treatment of iron deficiency anemia [IDA] in adult patients with chronic kidney disease [CKD]. Despite the use of recombinant erythropoietin, anemia remains a significant problem for patients with CKD and end-stage renal disease [ESRD]. As such, parenteral iron formulations in conjunction with erythropoietin have become standard practice. Iron replacement therapy… -
Biotech Deal Activity Declines…The Pause that Refreshes?
14 Jan 2010 | 7:54 pm* MD Becker Partners reporting live from the JP Morgan Healthcare Conference This week, nearly 6,500 registrants gathered in San Francisco, California for the JP Morgan Healthcare Conference to hear 25-minute presentations from 338 life science companies. For industry executives and investors, the annual event serves as a good barometer for the rest of the year. We roamed the familiar halls of the Westin St. Francis Hotel to assess the mood among participants and also monitored online media commentaries throughout the event. In general, there was a flurry of activity, the plane flights… -
2009: Biotech’s Stealth Small Cap Rally
3 Jan 2010 | 5:58 pmOn the heels of the Dow Jones Industrial Average (DJIA) logging its worst annual performance since 1931 and the NASDAQ Composite (COMP) having its worst year since inception in 1971, it may have seemed counter intuitive to provide a bullish outlook for the biotechnology industry in 2009. Nonetheless, at the start of the year we provided a positive outlook for biotechnology, citing the sector’s defensive characteristics, favorable technical aspects, and improving fundamentals, such as the number of new product approvals, products in clinical trials and the brisk pace of industry… -
Graft Versus Host Disease: Failures and Future Opportunities
9 Dec 2009 | 4:17 pmIn September 2009, Osiris Therapeutics, Inc. (OSIR) reported preliminary results from two Phase III trials evaluating its Prochymal product candidate for the treatment of acute Graft-versus-Host disease [GVHD]. Unfortunately, neither trial reached its primary endpoint, sending shares from $14 to a 52-week low of $5.35 by November 2009. The results were the latest in a number of late-stage, clinical trial setbacks for the treatment of GVHD [see table 1], prompting us to review this very complicated disease in search of future treatment opportunities. What is GVHD? When a cancer patient… -
Buyout Buzz at ASH Hematology Confab
7 Dec 2009 | 6:52 amScientific and medical advances weren’t the only topic of discussion at the 51st American Society of Hematology [ASH] Annual Meeting that began over the weekend in New Orleans, LA, as merger and acquisition activity took center stage. Early this morning, Celgene Corporation (CELG) announced the acquisition of privately-held Gloucester Pharmaceuticals for $340 million in cash plus another $300 million in future U.S. and international regulatory milestone payments. Gloucester’s Istodax® (romidepsin) was approved in November 2009, by the U.S. Food and Drug Administration [FDA] for the…
- Drug Channels
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CMS' New Drug Spending Projections
8 Feb 2010 | 11:00 pm“Prediction is very difficult, especially if it's about the future.” Niels Bohr The economists at the Centers for Medicare & Medicaid Services (CMS) just released their 2010 projections for U.S. National Health Expenditures (NHE). Here are two key observations about the prescription drug numbers. The Government Pays More, Starting Now—Public funds continue to crowd out private payers. CMS now projects that private insurance and public funds will each pay 40% of retail drug spending in 2010. By 2019, public funds will be almost half of outpatient retail prescription spending. Drug... -
Obama's Budget and Wholesaler Inventories
3 Feb 2010 | 11:00 pmPresident Obama submitted his fiscal year 2011 budget this week. The Wall Street Journal calls it “one of the greatest spend-while-you-can documents in American history.” POTUS’ budget wish list once again included the repeal of the Last-In, First-Out (LIFO) inventory valuation method, an apparently obscure accounting change with major implications for the public pharmaceutical wholesalers—AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH), and McKesson (NYSE:MCK). There is no legitimate business reason to repeal LIFO, so recognize that this proposal is nothing more than a $59… -
Won’t get FULed again
1 Feb 2010 | 11:00 pmList-price based reimbursement took another hit last week in the long-running multi-district litigation concerning allegedly inflated list prices such as Average Wholesale Price (AWP) and Wholesale Acquisition Cost (WAC). The ruling disclosed truly eye-popping (50,000%+) spreads between pharmacy acquisition costs and the published list prices for generic drugs. Once again, we learn just how flawed Medicaid’s existing Federal Upper Limit (FUL) computations have been for pharmacy reimbursement. The evidence of generic mega-spreads at retail pharmacies also provides a counterpoint to… -
My Macroeconomic Outlook for 2010
27 Jan 2010 | 11:00 pmAnd now for something completely different. You can download my new free report called the 2010 Economic Outlook For Wholesale Distributors, courtesy of IBM. You will have register on the IBM site to download the report. Fair warning: This report is not about the pharmaceutical industry or about drug wholesalers. In this report, I explain today's macroeconomic dynamics and provide forecasts for major distribution sectors. I also examine employment, channel inventory levels, consumer spending, and the outlook for markets such as construction and industrial manufacturing. Allow me to... Please… -
Drug Wholesaler Earnings Preview: 2009Q4
24 Jan 2010 | 11:00 pmThis week, the big 3 drug wholesalers—AmerisourceBergen (NYSE:ABC), Cardinal Health (NYSE:CAH), and McKesson (NYSE:MCK)—will all report their financial results from the fourth calendar quarter of 2009. These financial reports and accompanying conference calls provide invaluable insights into the strategies and economics of companies within U.S. drug channels. Below are my thoughts on general business issues that you should listen for in these reports. As a service to Drug Channels readers, I am also including links to the earnings conference call webcasts for each company. If you don’t…

